BMY and ZGen present Phase 1B results for PEG-Interferon lambda in HCV patients

Nov 2 2009

Bristol-Myers Squibb Company (NYSE: BMY) and ZymoGenetics, Inc. (NASDAQ: ZGEN) today presented final results from a Phase 1b clinical trial of PEG-Interferon lambda administered with ribavirin in relapsed and treatment-naïve hepatitis C virus (HCV) patients.

The poster included data on 56 patients in the study. Antiviral activity was observed at all dose levels tested. The results will be presented at the American Association for the Study of the Liver Diseases annual meeting in Boston on November 3. Interim results were previously presented at the European Association for the Study of the Liver annual meeting in April 2009.

“There is a strong need for additional options for hepatitis C patients,” said Brian Daniels, M.D., senior vice president, Global Development & Medical Affairs, Bristol-Myers Squibb. “We are pursuing this investigational pathway to address the fact that although current interferons have been the backbone of therapy with meaningful efficacy, they are often poorly tolerated, leading to dose reductions, poor compliance and avoidance of treatment.”

“We are excited about the prospects for PEG-Interferon lambda as a potential HCV treatment,” said Eleanor L. Ramos, M.D., senior vice president and chief medical officer of ZymoGenetics. “There is a clear unmet medical need for an interferon with improved safety and tolerability. We look forward to obtaining additional clinical data on this promising investigational medicine.”

The Phase 1b clinical trial was designed to evaluate the safety and antiviral activity of PEG-Interferon lambda when given as a single agent or in combination with ribavirin in genotype 1 HCV patients with relapsed disease and in treatment-naïve patients.

In the single agent arm of the study with treatment-relapsed patients>

PEG-Interferon lambda demonstrated antiviral activity at all dose levels tested in both relapse and treatment naïve HCV patients. A majority of patients across all treatment arms achieved a greater than 2 log reduction in HCV RNA.

Of the patients in the single agent arm of the study, all 12 of those patients receiving 1.5 mcg/kg and 3.0mcg/kg weekly for four weeks achieved a greater than 2 log decrease in HCV RNA. Five of the 12 patients receiving 1.5 mcg/kg and 3.00mcg/kg every two weeks for four weeks achieved a greater than 2 log decrease in HCV RNA.

At PEG-Interferon lambda doses of 0.75 mcg/kg, 1.5 mcg/kg and 2.25 mcg/kg administered in combination with ribavirin in treatment-relapsed patients>

Treatment-naive patients, who were treated with 1.5 mcg/kg of PEG-Interferon lambda in combination with ribavirin>

The most common adverse events were fatigue (29%) and nausea (13%). There were minimal effects on neutrophil counts. Minimal constitutional symptoms or hematologic effects were observed with PEG-Interferon lambda given as a single agent or in combination with ribavirin. The majority of adverse events and laboratory changes were grade 1 or 2. Dose-limiting elevations in ALT or AST, with or without an increase in bilirubin, were dose-dependent and reversible.

Overall, the results of the study support moving to dose-ranging Phase 2 studies in treatment-naïve HCV patients.

Source: Bristol-Myers Squibb Company